HEAT Study:
Hydrogel Endovascular Aneurysm Treatment Trial
Hydrogel Embolic Coils
"Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms."
- Patients
600
- Country
US
- Clinical Centers
46
- Design
RCT (297 HES vs 303 BPC)
- Scope
Patients 18 – 75 y.o. with a untreated aneurysm, ruptured or unruptured, 3-14mm, H&H<4 treatable with Hydrocoils or Bare platinum coils.
- Purpose
Evaluate recurrence rates of second-generation hydrogel coils HydroCoils for treating aneurysms compared to bare platinum coils.
Endpoints
Aneurysm Recurrence Post procedure to 24 months, defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale, (assessed by Corelab)
Efficacy results
Aneurysm recurrence: 4.4% HES vs 15.4% BPC
Packing density: 32,5% HES vs 24,7% BPC (p<.001)
Initial complete occlusion: 17,8% HES vs 28,3% BPC
Retreatment: 5.2% HES vs 8.3% BPC
Safety results
Patients with event related to procedure/device: 21.6% HES vs 24.8% BPC
Mortality: 2.4% HES vs 3.0% BPC
Device or procedure-related hemorrhage: 1.7% HES vs 1.3% BPC
Study publications
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01407952
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Hydrogel Embolic Coils
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